Negotiating licenses between patent holders and generic producers: the Medicines Patent Pool

The Medicines Patent Pool (MPP), backed by the United Nations, is a mechanism that has been formed with the intention of increasing access to HIV medicines in the developing world by increasing their affordability. The MPP negotiates licenses between patent holders and generic producers to make and sell HIV medicines at affordable prices to those who need it. An analysis of the concept of patent pools can be found here and here.  

The latest is the license negotiated by the MPP between the patent holder, Gilead Sciences and given to Shilpa Medicare, a Karnataka based generic producer to produce five key HIV medicines for sale in over 100 countries. The five HIV medicines for which the license is given are tenofovir, emtricitabine, cobicistat, elvitegravir and a combination of the four known as “the Quad”. 

Although, the purpose of the license is to provide these medicines to the needy at affordable prices, MPP makes no commitment about the price and the sale price of the drugs is as set by the market. From the market price of these medicines, a royalty of 3-5 per cent will be paid by Shilpa Medicare to the patent holder, Gilead Sciences depending on the medicine. It is interesting to note that Gilead Sciences was the first company to enter into an agreement with the MPP. Swaraj's post on the same is available here.

Shilpa Medicare is the sixth license holder of drug patents held by Gilead Sciences, through an agreement negotiated via MPP. The five other generic producers who tapped into the MPP to obtain licenses of Gilead Sciences are Aurobindo, Shasun, Laurus, Hetero and Emcure. Aurobindo, additionally holds another set of license of  pediatric HIV medicine, which was licensed to MPP by ViiV Healthcare. (ViiV Healthcare's colloboration with MPP is covered here.) This enables Aurobindo, a generic producer to produce medicines patented by Gilead Sciences and ViiV Healthcare, enabling greater access to needy people at affordable prices. This also provides Aurobindo an opportunity to produce combination drugs using the drugs patented by Gilead Sciences and ViiV Healthcare, which is generally impossible as the patents are owned by different companies. Such combination techniques, facilitated by MPP are an important and much more effective part of HIV treatment, as patients find it easier to take one pill that combines different drugs as opposed to the same drugs separately. This opinion finds support within the medical community, including organisations such as Doctors Without Borders.

The MPP acts as an intermediary between the patent holders and the generic producers. The participation of the patent holders in MPP's pool is voluntary and is mainly composed of large drug makers. Generic producers who express an interest to tap into the patent pool are assessed on various criteria including quality. The generic producers are usually required to obtain approval from regulatory authorities such as the US FDA or the WHO pre-qualification programme to tap into the patent pool. There is also a license management process which ensures through mechanisms such as quarterly reviews that the MPP licenses actually result in impact. However, questions have been raised about the licensing agreement, an excellent analysis of which is available here.

This is a welcome measure for the people of the developing world who are, many a time, denied access to life saving HIV medicine mainly because of its expense. As MPP works through a platform of voluntary participation, there has rightly been a call for increased participation by companies that hold patents for HIV drugs through MPP, not only because this leads to increased access through greater affordability but also provides for effective treatment by making the possibility of combination therapy between drugs patented by different companies possible.